Cefpodoxime proxetil (CPDX-PR, CS-807) was given orally to 18 children with acute bacterial infections including 10 with acute tonsillitis, 3 with acute bronchitis, 1 with pneumonia, 3 with staphylococcal scalded skin syndrome and 1 with infectious impetigo. Daily dosages per kg bodyweight ranging from 7.5 to 18 mg were given in 2 or 3 divided doses per day for 5 to 15 days. Clinical responses were excellent in 3 (16.7%), good in 11 (61.1%), fair in 4 (22.2%) and poor in 0 (0%), with an overall efficacy rate of 77.8%. Good bacteriological responses were obtained in 6 out of the 7 cases from which pathogens were identified. No side effect was observed. The above results suggest that CPDX-PR is a useful new oral cephalosporin derivative for the treatment of bacterial infections in children.
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Ceftriaxone-related haemolysis resulted in the death of one of our patients (patient 2), and caused acute renal failure in the other (patient 1). The DATwas strongly positive for anti-C3d and anti-IgG in one case (patient 2), and for anti-C3d alone in the other (patient 1). The serum of patient 1 reacted with red blood cells only in the presence of ex vivo antigens, while that of patient 2 reacted positively to native ceftriaxone and its ex vivo antigen. In the latter patient, the antibodies appeared to cross-react with native cefotaxime whereas, in the first patient, they weakly cross-reacted only with the ex vivo antigens of cefotaxime and cefpodoxime proxetil.
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The antimicrobial activity of cefpodoxime, the active metabolite of the new cephalosporin ester cefpodoxime proxetil, in comparison to cefixime, cefotiam, cefuroxime, and cefotaxime was determined against a broad spectrum of freshly isolated gram-positive and gram-negative bacterial strains. Cefpodoxime was demonstrated to be inhibitory at concentrations of less than or equal to 1 mg/l against 90% of strains of Moraxella catarrhalis, Haemophilus influenzae, Escherichia coli (beta-lactamase- negative strains), Klebsiella spp., Serratia spp., Proteus mirabilis, Proteus vulgaris, Providencia spp., and Salmonella spp. This antimicrobial activity of cefpodoxime was generally superior to that of cefuroxime and similar to that of cefixime. Cefpodoxime was active at less than or equal to 1 mg/l against 50% of the members of beta-lactamase-producing Escherichia coli, Enterobacter cloacae, Enterobacter aerogenes, Citrobacter spp., and Morganella morganii. Cefpodoxime proved to be highly inhibitory against group A, B, and G streptococci and Streptococcus pneumoniae (MIC90 less than 0.015 mg/l). The MICs of cefpodoxime and those of the other cephalosporins were less than 2 mg/l for greater than or equal to 90% of the strains of Staphylococcus aureus and Staphylococcus epidermidis, with the exception of cefixime which had no activity with MICs below 8 mg/l against these bacteria. Pseudomonas spp., Acinetobacter spp., and Enterococcus spp. were resistant to cefpodoxime. The antibacterial activity of cefpodoxime was only to a minor degree influenced by different growth conditions with the exception of high inoculum sizes against some beta-lactamase producing strains of gram-negative bacilli.(ABSTRACT TRUNCATED AT 250 WORDS)
Multiple dose pharmacokinetics of a new third-generation cephalosporin, cefpodoxime, were evaluated in adults (15, 18-60 years) and elderly adults (10, greater than or equal to 70 years), all out-patients suffering from acute lower respiratory tract infection. A dose of 200 mg cefpodoxime proxetil (expressed in mg cefpodoxime) was administered 12-hourly for seven to ten days and timed blood samples were evaluated on days 0, 3, 5, 6/7 and on the last day of treatment. Results showed that the pharmacokinetics in adult and elderly patients were comparable with those of healthy volunteers and with each other, with the exception of one elderly patient with severe renal impairment. Dosage adjustment of cefpodoxime proxetil does not therefore appear to be necessary in the elderly unless there is evidence of severe renal insufficiency.
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BACKGROUND, OUTCOME AND METHODS: Observational study of the clinical efficacy and tolerance of the cefpodoxime proxetil preparation, Podomexef. The study was conducted from August 1996 to April 1997. A total of 549 practitioners participated, 2,734 patients were recruited, and the data of 2714 patients were analyzed.
In US, pneumococcal conjugate vaccine (PCV7) had reduced the burden of AOM and changed the profile of the disease. Prior to PCV7 implementation in France, AOM represented 8% of pediatricians visits and failure rate was 12%. The aim of this study is to describe the epidemiologic characteristics of AOM after PCV7 implementation.
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Cefpodoxime is a semi-synthetic, third generation cephalosporin. The drug is available for use as a prodrug-Cefpodoxime proxetil, which is absorbed readily from the gut. It reaches adequate levels exceeding the MIC in most of the body fluids. It is excreted by kidneys, unchanged. Dose needs adjustment in compromised renal function. The drug is active against common gram-positive cocci like staphylococci including penicillinase producing strains, streptococci and gram negative bacteria like Hemophilus, E. coli, Klebsiella, Moraxella, Meningococci, Gonococci etc. The drug is useful in common upper and lower respiratory tract infections, sinusitis, and otitis media. The drug is also used in skin and soft tissue infections, urinary tract infection and respiratory tract infection. Cefpodoxime is being used as a step down from parenteral cephalosporin. The recommended dose is 8-10 mg/kg/d in a single or two doses. Different schedules have been given for different infections. The drug is safe, effective as a short course (5 vs. 10 days). With a low incidence of side effects, and twice a day dosing, it proves to be a useful drug.
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The risk for a child to carry penicillin-resistant S. pneumoniae (MIC > or = 0.125 mg/l) did not increase after antibiotic treatment: 84 of 364 (23.1%) before, 70 of 364 (19.2%) after. There was a significant decrease of penicillin-susceptible S. pneumoniae carriage, 117 of 364 (32.1%) before treatment compared with 24 of 364 (6.6%) (P = 0.0001) after treatment. However, among the children carrying S. pneumoniae at the end of the treatment there was an increase in the percentage of penicillin-resistant pneumococci: 84 of 201 (41.8%) before treatment and 70 of 94 (74.5%) after treatment. Among the 94 children carrying S. pneumoniae at the end of the treatment, 22 did not harbor pneumococcus before, 16 carried another genotypically different serotype and 56 harbored the same serotype. Among these 56 children 2 patients harbored strains that had increased MICs for the tested beta-lactam antibiotics. The randomly amplified polymorphic DNA analysis showed that in one case, the strains were genetically different.
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The disposition of cefpodoxime in 24 subjects with various degrees of renal function after administration of a single oral dose of 200 mg of cefpodoxime proxetil (equivalent to 200 mg of cefpodoxime activity) was studied. Subjects were assigned to one of four groups (six per group): group I, normal renal function (creatinine clearance [CLCR], greater than ml/min); group II, mild renal impairment (CLCR, 50 to 80 ml/min); group III, moderate renal impairment (CLCR, 30 to 49 ml/min); or group IV, severe renal impairment (CLCR, 5 to 29 ml/min). Although cefpodoxime terminal elimination half-life in group I (2.55 +/- 0.25 h [mean +/- standard deviation]) was not significantly different from that in group II (3.53 +/- 0.74 h), the half-life values for group III (5.90 +/- 1.67 h) and group IV (9.80 +/- 1.21 h) were significantly prolonged compared with those of group I. The mean absorption rate constant was similar among groups and ranged from 0.68 to 0.85 h-1. All groups exhibited absorption lag-times which were comparable (0.30 to 0.41 h), and the apparent volume of distribution was similar among groups. Cefpodoxime apparent total body clearance (CLP/F) values in groups II, III, and IV (132 +/- 29, 112 +/- 41, and 55.7 +/- 9.9 ml/min, respectively) were significantly lower than that in group I (238 +/- 44 ml/min). Cefpodoxime CLP/F was positively correlated with CLCR (r2 = 0.79; P less than 0.05): CLP/F = (1.9 CLCR) + 18.4. Renal clearance also declined with decreasing renal function. Adjustments in cefpodoxime organism and on the site and severity of infection. Simulated plasma concentration-time data from this study suggest that 200 mg of cefpodoxime proxetil administered every 12 to 24 h to subjects with CLcr between 30 and 49 ml/min and 200-mg dose taken every 24 h by subjects with CLcr between 5 and 29 ml/min will maintain cefpodoxime concentration in plasma similar to those in subjects with normal renal function who receive a standard dosage mg every 12 h.
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It was found that 62.68% were males, 26% patients were in the age group 26-35 years, followed by 22.8% belonging to the age group 26-35 years. Maximum number of patients were diagnosed with ear (37.3%) and throat (36.2%) infections. The most frequently prescribed antibacterials were β-lactams (45.52%) followed by quinolones (26.31%). The most commonly used agent in penicillins was amoxicillin and clavulanic acid (21.74%), in cepahalosporins was cefpodoxime proxetil (5.49%) and in quinolones was gemifloxacin (14.41%). Further, 66.67% of the patients received single antibacterial drug and the average number of antibacterial agents prescribed per patient per course was found to be 1.58. It was also observed that 70.71% of the antibacterials were prescribed by oral route. The most concomitant conditions were found to be diabetes (10.5%), hypertension (6.16%) and coronary heart disease (5.07%). All the drugs were prescribed by their brand names and 48.91% patients showed good adherence with the prescribed therapy.
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Between October, 1996, and April, 1997, 450 children (mean age, 14.3 months) were enrolled, 227 in the 5-day group and 223 in the 10-day group. In the per protocol analysis clinical success was obtained on Days 12 to 14 after the beginning of treatment (main analysis) in 175 (84.1%) of the 208 children receiving the 5-day regimen and 194 (92.4%) of the 210 children receiving the 10-day regimen (P = 0.009). The superiority of the standard regimen was more marked among children cared for outside their homes (92.5% vs. 81.5%). Clinical success persisted on Days 28 to 42 among 134 (85.4%) of the 157 assessable patients in the 5-day group and 144 (83.7%) of the 172 assessable patients in the 10-day group (P = 0.68).
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CS-807 is a new cephalosporin orally available. The clinical efficacy and safety of this drug were evaluated in 13 patients with urinary tract infection, including 3 with simple cystitis and 10 with complicated infections. According to the response criteria defined by the Japanese UTI committee, the clinical effectiveness in 8 patients with complicated urinary tract infections regarded evaluable was excellent in 2, moderate in 4 and poor in 2, the overall efficacy rate being 75.0%. Only 1 of the 13 patients studied, developed temporary diarrhea as a drug related adverse reaction.
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Twelve patients with respiratory tract infections were treated with cefpodoxime proxetil (CS-807, CPDX-PR), a new cephem antibiotic. It was given orally at a dose of 200 mg 2 times a day for 4 approximately 15 days. Its clinical effects were evaluated as excellent in 1 case, good in 9 cases and poor in 2 cases. The efficacy rate was 83.3%. Its bacteriological effects were evaluated as eradication in 5 strains and decrement in 1 strain. The eradication rate was 83.3%. No adverse reactions and disorder of laboratory findings due to CPDX-PR were observed.
Learning about the behavior of a drug in biological environment enables application of better formulation strategies to improve bioavailability of the same. Cefpodoxime proxetil (CP) is a prodrug, which is orally administered cephalosporin with only 50% absolute bioavailability. Despite previous studies, reasons responsible for low bioavailability of CP remain poorly understood. The present study tries to ascertain reasons for the low oral bioavailability of CP. The in vitro, in situ and ex vivo studies showed interesting results, where metabolism of CP into cefpodoxime acid (CA) inside the intestinal epithelial cell and preferential efflux of CA into lumen was identified as primary reason for low oral bioavailability of CP. Presence of specific carriers or transportation mechanism on the apical side membrane of enterocyte, than basal side of the same was observed.
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Cefpodoxime, the deesterified part of the orally available cefpodoxime proxetil, is active against most Enterobacteriaceae with MIC50 of 0.06 to 2 mg/l. Only Enterobacter cloacae and Citrobacter freundii strains show MIC50 of 4 mg/l. Coagulase negative staphylococci have a MIC50 of 2, while Staphylococcus aureus strains have a MIC of 4 mg/l. In comparison to other orally available cephalosporins cefpodoxime is slightly less active than cefixime and cefotiam against gram-negative bacteria but more active than cefuroxime, cefaclor, and cephalexin. Against staphylococci the activity of cefpodoxime is comparable to that of cefotiam and cefuroxime and superior to cefaclor and cephalexin, while cefixime does not have sufficient activity against these species. Like all cephalosporins cefpodoxime has no activity against enterococci.